Neoadjuvant PDT in the Treatment of Cholangiocarcinoma

NCT04824742 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Phase

Not applicable

Started

2021-04-01

Last updated

2021-04-01

Condition(s) studied

Cholangiocarcinoma Resectable

Investigational drug(s) / intervention(s)

Neoadjuvant PDT + radical surgeryRadical surgery

Neoadjuvant PDT + radical surgery: Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy

Radical surgery: Patients with cholangiocarcinoma will only receive radical surgery

Study summary

For patients with locally advanced cholangiocarcinoma with resectable margins, patients who meet the selection criteria are randomly divided into two groups A and B. Group A: neoadjuvant PDT therapy combined with radical surgery; Group B: radical surgery. This study aims to explore the clinical effectiveness and safety of neoadjuvant photodynamic therapy for cholangiocarcinoma, as well as its role in destroying local tumors and enhancing systemic inflammation.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Patients with age between 18 to 75 years; * Patients'gender was not limited; * Patients with locally advanced cholangiocarcinoma who have a clear diagnosis of the primary disease and require surgical resection or potential surgical resection; * No history of radiotherapy and chemotherapy; * Willing to accept this clinical trial, sign informed consent and be able to cooperate with follow-up. Exclusion Criteria: * Women during pregnancy or breastfeeding, and those with mental illness; * Patients allergic to porphyrin drugs, porphyria; * Long-term use of glucocorticoids or autoimmune suppression; * Surgical contraindication, including: Child-Pugh C with hepatic encephalopathy Anyone with heart, lung, kidney dysfunction or other organ dysfunction, and cannot tolerate surgery.Hepatic ducts stone disease, who was diagnosed as Acute Cholangitis of Severe Type, especially complicated with bacteremia or septic shock. End stage disease, complicated with biliary cirrhosis or portal hypertension.Patients with long- term obstructive jaundice, dehydration, electrolyte disturbance or coagulation defects; Patients have the tendency or history of bleeding.

Primary outcome measure(s)

R0 resection rate — During operation
Compare the incidence of positive margins of bile duct after surgical resection of cholangiocarcinoma between the two groups
Local recurrence rate — 1-year post operation
Compare the local recurrence rate of cholangiocarcinoma between the two groups
Survival time — 5-year post operation
Compare the 5-year survival time of the two groups

Trial sites (1)

Facility	City	Region	Status
Yi Lv	Xi'an	Shaanxi

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04824742 on ClinicalTrials.gov ↗ ← All trials in China